(29 days)
A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
DISPOSABLE POWDER FREE VINYL EXAM GLOVES
I am sorry, but I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text. The document is an FDA 510(k) clearance letter for "Disposable Powder Free Vinyl Exam Gloves," dated August 14, 2003.
This type of document primarily confirms that the FDA has reviewed the device and determined it is "substantially equivalent" to a legally marketed predicate device. It certifies that the device can proceed to market under general controls.
The letter does not contain:
- Specific acceptance criteria (such as performance metrics like tensile strength, elongation, or barrier integrity). While such criteria would have been part of the manufacturer's submission, they are not detailed in this clearance letter.
- Details of the study or tests performed by Symertex Company Limited to demonstrate compliance with performance standards. The FDA's review in a 510(k) typically relies on the manufacturer's data demonstrating that their device meets recognized standards or is substantially equivalent to a predicate.
- Information regarding sample sizes, data provenance, expert qualifications, ground truth establishment, or multi-reader multi-case studies. These are typically associated with more complex medical devices that involve diagnostic or therapeutic algorithms, not examination gloves.
The document states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..." This statement clearly indicates the basis for clearance is substantial equivalence to a predicate, not necessarily detailed performance study results within this letter itself.
Therefore, I cannot extract the requested information from the provided text.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.